SPL v1
SPL
SPL Set ID 9e0979d6-4aa6-49e4-bc19-bf1600e2adb0
Route
TOPICAL
Published
Effective Date 2020-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (75 mL)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Peppermint Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-18

Description

Ethyl Alcohol 75% v/v.

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 75% v/v.

Use
  • To decrease bacteria on the skin that coucld cause disease.
  • Recommended for repeated use.
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings

For external use only:hands.

Flammable. Keep away from heat or flame.

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.
  • Stop use and ask a doctor if
  • irritation or redness develops.
  • Condition persists for more than 72 hours.
Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information
  • Do not store above 1050F
  • May discolor certain fabrics.
  • Harmful to wood finishes and plastics
Inactive Ingredients

Water (Aqua), Isopropyl alcohol, Plant pharma glycerin, Peppermint oil.

Package Label Principal Display Panel


Structured Label Content

Use
  • To decrease bacteria on the skin that coucld cause disease.
  • Recommended for repeated use.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Antiseptic

Warnings

For external use only:hands.

Flammable. Keep away from heat or flame.

When using this product

  • keep out of eyes. In case of contact with eyes, flush thoroughly with water.
  • Avoid contact with broken skin.
  • Do not inhale or ingest.
  • Stop use and ask a doctor if
  • irritation or redness develops.
  • Condition persists for more than 72 hours.
Directions
  • Wet hands thoroughly with product and allow to dry without wiping.
  • For children under 6, use only under adult supervision.
  • Not recommended for infants.
Active Ingredient

Ethyl Alcohol 75% v/v.

Other Information (Other information)
  • Do not store above 1050F
  • May discolor certain fabrics.
  • Harmful to wood finishes and plastics
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl alcohol, Plant pharma glycerin, Peppermint oil.

Package Label Principal Display Panel (Package Label - Principal Display Panel)


Advanced Ingredient Data


Raw Label Data

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